# Development of a novel technology for the determination of a physiologic phenotype in patients with Systemic Lupus Erythematosus

> **NIH NIH R43** · ALGOMETRX, INC. · 2022 · $272,392

## Abstract

In this application, we propose the initial validation of a novel medical device for the measurement of systemic
lupus erythematosus (SLE) disease activity. SLE is a complex inflammatory disease involving many organ
systems. The existing assessment tools and laboratory tests used to track inflammation do not reliably reflect
patient reported symptoms. Furthermore, these biomarkers are unable to predict the onset of a flare state.
Studies have shown that patients with well managed lupus accumulate less organ damage and demonstrate
improved outcomes over time. There is an unmet clinical need for reliable biomarkers that reflect disease
activity to facilitate the treatment of a specific SLE disease activity phenotype and severity. This measure
would help to guide the adequacy of immunosuppressive therapy or indicate a need to treat other symptoms.
Regular monitoring of such an endpoint has the potential to predict a flare in activity, which would enable early,
preemptive interventions and improve patient outcomes. AlgometRx Inc., was spun out of Children’s National
Hospital (CNH) to develop and commercialize the novel technology being used in this proposal. This device is
a novel integration of non-invasive and innocuous neuroselective electrical stimulation with infrared
pupillometry to activate specific sensory nerve fiber types and allows for an objective quantified
characterization of sensory nerve fiber activity. Specifically, this technology measures the impact of SLE-
associated inflammation on sensory nerve fiber activity. The resulting SLE Index enables comparisons
between measures over time within an individual as well as between individuals. In this proposal, we plan to
expand upon our preliminary data in the development of an easily implemented, non-invasive and objective
physiologic measure of SLE disease activity. To accomplish this, we propose the following aim and approach:
Aim: Establish the initial validation of the SLE Index as an objective measure of SLE disease activity.
We will enroll 20 SLE patients referred to the Multidisciplinary Lupus Clinic at CNH and assess their lupus
disease activity each month for 6 to 12 months. During each clinic visit, assessment of a patient’s SLE disease
activity will be performed using the SLEDAI-2K clinical assessment tool and our device. We will establish the
initial validation of the SLE Index as a measure of disease activity by assessing sensitivity, specificity, and
reliability of the SLE Index. After this initial validation against the SLEDAI-2K, we plan to follow with a Phase II
proposal that will further validate the index and will facilitate a larger study to quantify the impact of treatments
in patients with SLE. The Phase II will also inform our need for additional data in support of an initial FDA
clearance as a device for the monitoring of SLE disease activity. The application being developed in this
proposal will enable early detection of a flare state, optimize SLE phenotype- and ...

## Key facts

- **NIH application ID:** 10597545
- **Project number:** 1R43AR082160-01
- **Recipient organization:** ALGOMETRX, INC.
- **Principal Investigator:** Julia Cole Finkel
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $272,392
- **Award type:** 1
- **Project period:** 2022-09-22 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10597545

## Citation

> US National Institutes of Health, RePORTER application 10597545, Development of a novel technology for the determination of a physiologic phenotype in patients with Systemic Lupus Erythematosus (1R43AR082160-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10597545. Licensed CC0.

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